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510(k) Data Aggregation

    K Number
    K232431
    Device Name
    syngo.CT Brain Hemorrhage
    Manufacturer
    Siemens Medical Solutions USA, Inc.
    Date Cleared
    2024-03-22

    (224 days)

    Product Code
    QAS
    Regulation Number
    892.2080
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K203260
    Predicate For
    K243145
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    syngo.CT Brain Hemorrhage is designed to assist the radiologist in prioritizing cases of suspected intracranial hemorrhage, also in the subarachnoid space, on non-contrast CT examinations of the head. It makes case-level output available to a CT scanner or other PACS system for worklist prioritization. The output is intended for informational purposes only and is not intended for diagnostic use. The device does not alter the original medical image and is not intended to be used as a standalone diagnostic device.

    Device Description

    The subject device syngo.CT Brain Hemorrhage is an image-processing software that uses an artificial intelligence algorithm to support qualified clinicians in the analysis and prioritization of non-contrast head CT images. It is a notification-only processing application that algorithmically identifies findings suspicious of acute intracranial hemorrhage (ICH) and acute subarachnoid hemorrhage (SAH). The subject device facilitates a parallel workflow, where cases suspected of presence of ICH or SAH are flagged. The device does not mark, highlight, or direct users' attention to a specific location in the original image. The device does not remove cases from a reading queue.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study details for the syngo.CT Brain Hemorrhage device, based on the provided text:

    Acceptance Criteria and Device Performance

    Acceptance Criteria (Performance Goal)Reported Device Performance (Intracranial Hemorrhage)Reported Device Performance (Subarachnoid Hemorrhage)
    Sensitivity ≥ 80%95.0% (95% CI: 92.5%-96.7%)86.1% (95% CI: 81.1%-90.0%)
    Specificity ≥ 80%93.1% (95% CI: 90.5%-95.1%)85.2% (95% CI: 82.3%-87.7%)

    Study Details

    1. Sample size used for the test set and the data provenance:

      • Sample Size: 900 anonymized head CT cases.
      • Data Provenance: From 5 sites in the US and Europe. The distribution of positive (case with ICH) and negative (case without ICH) cases was approximately equal.
      • Type: Retrospective (implied by "anonymized head CT cases from 5 sites").

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

      • Number of Experts: 3
      • Qualifications: US board-certified neuroradiologists with more than 10 years of experience.

    3. Adjudication method for the test set:

      • Method: Majority read (e.g., 2 out of 3 experts agreed).

    4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The study described is a standalone performance study.

    5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the document explicitly states: "The performance of the syngo.CT Brain Hemorrhage device has been va alone performance study."

    6. The type of ground truth used: Expert consensus, established by the majority read of 3 US board-certified neuroradiologists.

    7. The sample size for the training set: 29,713 cases.

    8. How the ground truth for the training set was established: The document does not explicitly state how the ground truth for the training set was established. It only mentions the training data size.

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